
TMF management is becoming increasingly specialised. This specialisation is attributable to a host of factors – globalisation; a matrix of overlapping regional and international regulations; emerging technologies; and interdependence of TMF professionals and professionals in other functional units.
We are expanding the TMF Institute globally to meet the growing demand for targeted professional development, training and education for the TMF professionals and allies. We created the TMF Institute by incorporating what participants like most about the TMF Summit series’ workshops into an objective-driven professional growth and learning opportunity. Each of the TMF Institute daylong courses provide information and develop skills essential to specific to a specialized job function or level or responsibility
The TMF Institute consists of a slate of four courses to meet the professional development and educational needs growing TMF community. The instructors and all facets (e.g., content, activities, discussion topics) of each course are determined by what participants need to know and be able to do to excel in a particular purview or echelon.
Who Should Participate
Professionals from pharmaceutical, biotech, and medical device organisations as well as CROs, vendors, and eTMF/TMF service providers having or seeking responsibilities in the following areas:
- TMF/eTMF Systems Management
- Clinical Document Management
- Clinical Trial Documentation
- Clinical Trial Administration
- Clinical/TMF Project Management
- Quality Control/Quality Management
- Clinical Operations
- Clinical Research Coordination/Management
- Regulatory Affairs/Operations
- Business
- Trial Records Management
- Clinical Process
- Clinical Trial Compliance
- Clinical Development
- Quality Assurance/Control/Operations
- R&D Quality Management
- Strategic Operations and Planning
- Global Development
- R&D IS Management
- Archives
Leading International Experts

Kristen Bretzius
Document Center Manager PSI PHARMA SUPPORT AMERICA
Martina Duevel
Systems Excellence Project Leader BAYER
Cristoph Gerdts
IT Business Partner Clinical BAYER BUSINESS SERVICE GMBH / BAYER AG
Martin Hausten
Head of Global Documentation Quality Centre EU BOEHRINGER INGELHEIM
Andreas Järemo
Associate Director Enablement, TMF Global Lead ASTRAZENECA
Claudia Panitz
Head eDMS Center of Excellence/Regulatory Readiness NOVARTIS
Timothy Rafferty
eTMF Quality and Metrics Manager ROCHE
Eldin Rammell
Director HEALTH SCIENCES RECORDS & ARCHIVES ASSOCIATION
Edith Tapie
TMF Repository Support Lead, TMF Governance Office NOVARTIS
Jamie Toth
Director and Head of TMF Operations DAIICHI SANKYO
Wendy Trimboli
Director, Head of TMF Management and Compliance EISAI